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NCT07537023
Family-Centered Affective Stimulation for Patients With Traumatic Brain Injury: Its Effects on Coma Recovery
NA trial testing Family-Centered Affective Stimulation (FCAS) in Patients With Traumatic Brain Injury in 120 participants. Completed in 30 October 2025.
30 October 2025
Quick facts
| Lead sponsor | Cairo University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 120 |
| Start date | 2 May 2025 |
| Primary completion | 30 October 2025 |
| Estimated completion | 30 October 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Family-Centered Affective Stimulation (FCAS)
Conditions studied
- Patients With Traumatic Brain Injury — all drugs for Patients With Traumatic Brain Injury →
- Coma, Traumatic — all drugs for Coma, Traumatic →
Sponsor
Cairo University
Who can join
Adults 18 to 60, any sex, with Patients With Traumatic Brain Injury or Coma, Traumatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Family-centered affective stimulation involves creating an environment in which family members actively participate in the patient's recovery by providing emotional support, positive reinforcement, and a supportive presence. The family-centered affective simulation effects on coma recovery in patients afflicted with traumatic brain injury were the aim of this study. A quasi-experimental design was employed with 120 patients, who were assigned to either the family stimulation group (n = 60) or the control group (n = 60) in a random manner. Validated instruments, encompassing the Modified Early Warning Score (MEWS), Full Outline of Unresponsiveness (FOUR) score, and Coma Recovery Scale-Revised (CRS-R), were used to assess outcomes of coma recovery. Chi-square tests, independent and paired t-tests, and correlation coefficients were employed to analyze the data. Following the implementation of family stimulation, highly statistically significant differences were evident in patients' deterioration risk scores, consciousness level scores, and mean coma recovery scores among the studied groups (p = 0.001). Additionally, the family stimulation group showed significant improvement between pre- and post-study phases (p \< 0.001). The application of family-centered organized affective stimulation is an efficient and practical approach to enhance consciousness levels and coma recovery outcomes in comatose patients. Nurses can integrate sensory stimulation into existing therapeutic interventions, either independently or in collaboration with patients' families.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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- PubMed search for NCT07537023
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07537023 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cairo University
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07537023.
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